Evaluation of the Efficacy of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Unilateral Neglect in Patients With Subacute-Chronic Phase After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Line Bisection Test
研究概览
简要总结
The aim of this study was to randomize stroke patients with unilateral neglect into 2 groups, active and sham groups, and to examine the effects of active inhibitory repetitive transcranial magnetic stimulation on the reduction of neglect symptoms, functional recovery and independence of these patients in activities of daily living.
详细描述
Patients diagnosed with ischemic stroke at least 1 month ago, with unilateral neglect, receiving inpatient rehabilitation at stroke clinics, and meeting the study criteria for both genders between the ages of 18-80, will be divided into two groups. A total of 22 stroke patients, informed about the applied treatments and potential risks, and providing written consent, will be randomly assigned to receive either active repetitive transcranial magnetic stimulation (rTMS) combined with conventional rehabilitation (Mirror therapy and Visual scanning training) or sham (imitation) repetitive transcranial magnetic stimulation (rTMS) combined with conventional rehabilitation.
The study will include 22 randomly selected patients with neglect, with 11 planned in the intervention group and 11 in the control group. Patients will receive active rTMS or sham rTMS for a total of 10 sessions, each lasting 20 minutes, alongside conventional rehabilitation over a period of 2 weeks. rTMS applications will be conducted once daily before the daily rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-time ischemic stroke
- •Patients at least 1 month after the stroke
- •To be aged between 18 and 80 years old
- •Presence of unilateral neglect
- •No significant cognitive impairment (MMSE > 24 points)
- •Signing an informed consent form indicating willingness to participate in the study
排除标准
- •Epilepsy, history of seizure
- •Metallic implant in the area of stimulation (cochlear implant, brain pacemaker, drug pump etc.)
- •Presence of cardiac pacemaker
- •Severe general condition disorder or accompanying neurological disease
- •Pregnancy
- •Under 18 years of age and over 80 years of age
- •Visual impairment
研究组 & 干预措施
Active repetitive transcranial magnetic stimulation in stroke patients with unilateral neglect.
Inhibitory repetitive transcranial magnetic stimulation will be applied to 11 patients with unilateral neglect due to ischemic stroke under the supervision of a doctor for a total of 10 sessions over 2 weeks with conventional rehabilitation. Each session will last for 20 minutes,total of 1200 pulses, 1 Hz repetitive transcranial manyetic stimulation over the unaffected left posterior parietal cortex.
干预措施: Active Repetitive Transcranial Magnetic Stimulation (Device)
Sham repetitive transcranial magnetic stimulation in stroke patients with unilateral neglect.
Patients in the sham group will receive sham transcranial magnetic stimulation with sham coil for 20 minutes a day, 10 sessions in total, together with conventional rehabilitation.
干预措施: Sham Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Line Bisection Test
时间窗: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
The Line Bisection Test is a rapid measure to detect the presence of unilateral spatial neglect. To complete the test, a pencil mark is placed in the middle of 18 horizontal lines. The test is scored by measuring the deviation from the actual center of the line.
Star Cancellation Test
时间窗: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
The star cancellation test, there are 13 letters and 10 short words placed between 52 large and 56 small stars. The patient is required to mark all the small stars using a pencil. To demonstrate how it should be done, two small stars are selected from the central section.Scores are calculated by identifying the ratio of the number of removed small stars/the total number of small stars 100 for each empty half-space on the left and right sides.
次要结局
- Stroke Impact Scale(Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment)
- Mini-Mental State Examination(Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment)
- Brunnstrom Recovery Stage(Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment)
- Catherine Bergego Scale(Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment)
研究者
Ayşenur Mert
Medical doctor
Ankara City Hospital Bilkent